Learning MRI and Histology Image Mappings for Cancer Diag... | NCT04792138

Studies
Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis.

NCT04792138

Sponsor

University College, London

Status

Unknown status

Last Update Posted

Mar 10, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Prostate Cancer
Prostate Neoplasm

Interventions

VERDICT MRI
Luminal Index Imaging

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2020Actual

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Mar 2, 2021

First Submission Date that Met QC Criteria

Mar 8, 2021

First Posted Date

Mar 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2021

Last Update Posted Date

Mar 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multiparametric magnetic resonance imaging (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively before men undergo biopsy. Before these techniques are translated clinically, robust histological and clinical validation is required.

This study aims to clinically validate advanced MRI techniques in a cohort of men suspected with prostate cancer. Histological analysis of men undergoing biopsy, +/- prostatectomy will be used for biological validation of VERDICT; Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging (LWI). In particular, prostatectomy specimens will be processed using 3-D printed patient-specific moulds to allow for accurate MRI and histology mapping.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Men suspected of Prostate Cancer			Diagnostic Test: VERDICT MRI Diagnostic Test: Luminal Index Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VERDICT MRI	Diagnostic Test	Advanced Diffusion Model	Men suspected of Prostate Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy of VERDICT MRI	Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone	2 years
Diagnostic accuracy of Luminal Water Imaging (LWI)	Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone	2 years

Secondary Outcomes

Measure	Description	Time Frame
The proportions of true positives with index tests is the same as mpMRI.		2 years

Other Outcomes

Measure	Description	Time Frame
Machine learning algorithms can predict histology from MRI.	Number of correct predictions of gleason grade in men who undergo biopsy or prostatectomy.	3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men aged 18-90 with a clinical suspicion of prostate cancer
No contraindication to MRI

Exclusion Criteria

Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
Men unable to given informed consent
Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
Ongoing hormonal treatment for prostate cancer

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Participant eligibility is based on self-representation of gender identity. Men with clinical suspicion of prostate cancer.

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Cohort of men presenting to our recruitment centre with suspicion of prostate cancer due to raised prostate specific antigen level or suspicious clinical examination.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joey Clemente	Contact	07886178028		j.clemente@nhs.net

Overall Officials

Name	Affiliation	Role
Shonit Punwani	University College, London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University College London Hospital	Recruiting	London			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35396316	Derived	Singh S, Mathew M, Mertzanidou T, Suman S, Clemente J, Retter A, Papoutsaki MV, Smith L, Grussu F, Kasivisvanathan V, Grey A, Dinneen E, Shaw G, Carter M, Patel D, Moore CM, Atkinson D, Panagiotaki E, Haider A, Freeman A, Alexander D, Punwani S. Histo-MRI map study protocol: a prospective cohort study mapping MRI to histology for biomarker validation and prediction of prostate cancer. BMJ Open. 2022 Apr 8;12(4):e059847. doi: 10.1136/bmjopen-2021-059847.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms